Job Title: GCP Quality Assurance Manager
Location: PA, NJ, NY, MD, DE
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
As a Manager of GCP Quality Assurance, you will be responsible for ensuring the quality and compliance of the organizations clinical trials with applicable regulations, guidelines, industry standards, and best practices.
- Ensure that clinical trial vendors operate in compliance with the organization’s quality program, regulation/guidelines, and SOPs through Qualification audits and oversight activities will be a key responsibility
- Develop Quality Agreements and conduct routine meetings to help establish effective partnerships with external vendors
- Collaborate with the QA department and cross-functional teams in order to achieve compliance standards while contributing to a risk-based Quality Management System
- Contribute to annual audit plans and schedules for GCP/GLP vendors, and clinical study sites
- Liaise with stakeholders to obtain responses to audit findings and ensuring timely closure of any identified issues
Position Requirements: Bachelor’s Degree Required, Scientific Discipline
- Experience in preparing for inspections or providing support during regulatory agency inspections
- Ability to collaborate cross-functionally and build collaborative relationships both externally and internally
- Strong understanding of the cross-functional drug development process, particularly in relation to clinical trial operations, data management, statistics, etc.
- Demonstrable knowledge of GCP as well as a familiarity with GLP
- Ability to troubleshoot as well as make rational, timely, and compliant risk-based decisions
We welcome the opportunity to provide a full job description upon resume review.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.